Events

Retiro De Equipo (Recall) de Device Recall Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fu

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Siemens Medical Solutions USA, Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    64678
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1097-2013
  • Fecha de inicio del evento
    2013-01-15
  • Fecha de publicación del evento
    2013-04-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116754
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • Causa
    Siemens has become aware of a potential malfunction and possible hazard to patients and staff when using the iconos r200 c20, iconos r200 t20, iconos r100, iconos md, iconos rhd, luminos rf classic, luminos fusion or luminos select. this malfunction is possible in cases where the table vertical lift movement is obstructed by a solid object which could potentially result in collision. this can re.
  • Acción
    Siemens sent a Customer Safety Advisory letter dated January 15th, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The SIEMENS service representative will investigate if parts need to be exchanged in your product, an if so, which parts need to be exchanged to restore the system safety and function. Please kindly confirm receipt of the Field Safety Notice by sending back the attached form. For further questions please call (610) 448-3237.

Device

Device Recall Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF C...
  • Modelo / Serial
    Model Number 5902767 with serial numbers 2217, 2038, 1228, 1007, 1219, 2156, 2264, 2190, 2132, 2213, 1484, 2166, 2259, 2068, 1610, 1601, 1413, 2236, 2153, 1444, 1477, 1632, 2037, 2180, 1663, and 1612; Model Number 5902783 with serial numbers 1003, 1401, 1402, and 1405; Model Number 7152478 with serial numbers 2580, 2524, 2590, 2536, 2563, and 2534; Model Number 10093962 with serial numbers 5837, 5120, 5523, 5910, 5507, 6141, 4112, 6274, 4506, 5900, 4121, 6245, 6242, 4509, and 6113.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the states of CA, FL, GA, IA, IN, KS, LA, ME, MI, MO, NC, NH, NJ, NY, NV, OH, PA, TN, TX, VA and WA.
  • Descripción del producto
    Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. || Angiographic x-ray system.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA